A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis

Last updated: February 13, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

2

Condition

Atopic Dermatitis

Eczema (Atopic Dermatitis)

Dermatitis, Atopic

Treatment

Afimkibart

Clinical Study ID

NCT07223697
CS45943
2025-520771-59-00
  • Ages > 18
  • All Genders

Study Summary

This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability and willingness to comply with all aspects of the protocol includingcompletion of the efficacy assessments (EASI and IGA), clinical outcome assessmentinstruments (DLQI, POEM), and safety and PK sample collections for the duration ofthe study

Parent Clinical Trial-Specific Criteria:

  • Study CS45570 participants who continued to be evaluated at the Week 36 follow upvisit and achieved => EASI50 response from study baseline

Exclusion

Exclusion Criteria:

  • Evidence of other skin conditions that would interfere with the assessment of AD

  • Withdrawal of consent and/or premature discontinuation from parent study

  • Any permanent discontinuation of study drug in parent study

  • History of severe allergic reaction or anaphylactic reaction to any biologic agentor known hypersensitivity to any component of Afimkibart

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Afimkibart
Phase: 2
Study Start date:
January 08, 2026
Estimated Completion Date:
February 11, 2033

Connect with a study center

  • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

    Rzeszów 759734, 35-055
    Poland

    Active - Recruiting

  • Revival Research Institute, LLC

    Troy 5012639, Michigan 5001836 48084
    United States

    Active - Recruiting

  • Best Skin Research LLC

    Camp Hill 5182928, Pennsylvania 6254927 17011
    United States

    Active - Recruiting

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